[Federal Register Volume 74, Number 230 (Wednesday, December 2, 2009)]
[Notices]
[Page 63156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-28827]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Importer of Controlled Substances; Notice of Application

    Pursuant to 21 U.S.C. 958(i), the Attorney General shall, prior to 
issuing a registration under this Section to a bulk manufacturer of a 
controlled substance in schedule I or II, and prior to issuing a 
regulation under 21 U.S.C. 952(a)(2), authorizing the importation of 
such a substance, provide manufacturers holding registrations for the 
bulk manufacture of the substance an opportunity for a hearing.
    Therefore, in accordance with 21 CFR 1301.34(a), this is notice 
that on October 8, 2009, Mylan Pharmaceuticals Inc., 781 Chestnut Ridge 
Road, Morgantown, West Virginia 26505, made application by letter to 
the Drug Enforcement Administration (DEA) to be registered as an 
importer of the basic classes of controlled substances listed in 
schedule II:

------------------------------------------------------------------------
                             Drug                               Schedule
------------------------------------------------------------------------
Oxycodone (9143).............................................         II
Hydromorphone (9150).........................................         II
------------------------------------------------------------------------

    The company plans to import the listed controlled substances as 
finished dosage forms (FDF) for analytical testing and distribution for 
clinical trials.
    Any bulk manufacturer who is presently, or is applying to be, 
registered with DEA to manufacture such basic classes of controlled 
substances may file comments or objections to the issuance of the 
proposed registration and may, at the same time, file a written request 
for a hearing on such application pursuant to 21 CFR 1301.43, and in 
such form as prescribed by 21 CFR 1316.47.
    Any such comments or objections should be addressed, in 
quintuplicate, to the Drug Enforcement Administration, Office of 
Diversion Control, Federal Register Representative (ODL), 8701 
Morrissette Drive, Springfield, Virginia 22152; and must be filed no 
later than January 4, 2010.
    This procedure is to be conducted simultaneously with, and 
independent of, the procedures described in 21 CFR 1301.34(b), (c), 
(d), (e), and (f). As noted in a previous notice published in the 
Federal Register on September 23, 1975, (40 FR 43745-46), all 
applicants for registration to import a basic class of any controlled 
substance in schedule I or II are, and will continue to be, required to 
demonstrate to the Deputy Assistant Administrator, Office of Diversion 
Control, Drug Enforcement Administration, that the requirements for 
such registration pursuant to 21 U.S.C. 958(a); 21 U.S.C. 823(a); and 
21 CFR 1301.34(b), (c), (d), (e), and (f) are satisfied.

     Dated: November 23, 2009.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control, Drug 
Enforcement Administration.
[FR Doc. E9-28827 Filed 12-1-09; 8:45 am]
BILLING CODE 4410-09-P